Phase 3
Completed N=530
DHEA Against Vaginal Atrophy - Safety Study of 12 Months
Source: ClinicalTrials.gov NCT01256671 ↗Enrolled (actual)
530
Serious AEs
3.5%
Results posted
Oct 2017
Primary outcomePrimary: Long-term Safety of Intravaginal Prasterone (DHEA): Endometrium — 421; 36 Participants
◆ Published Evidence
Established
90citations · ~8 / year
Lack of effect of intravaginal dehydroepiandrosterone (DHEA, prasterone) on the endometrium in postmenopausal women.
Summary
The purpose of this Phase III trial is to assess the long-term safety of intravaginal dehydroepiandrosterone (DHEA) in non-hysterectomized postmenopausal women with vaginal atrophy aged 40 to 75 years.
Linked Publications (5)
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Lack of effect of intravaginal dehydroepiandrosterone (DHEA, prasterone) on the endometrium in postmenopausal women.
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Serum steroid concentrations remain within normal postmenopausal values in women receiving daily 6.5mg intravaginal prasterone for 12 weeks.
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Prasterone has parallel beneficial effects on the main symptoms of vulvovaginal atrophy: 52-week open-label study.
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Effect of intravaginal dehydroepiandrosterone (DHEA) on the female sexual function in postmenopausal women: ERC-230 open-label study.
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Serum steroids remain within the same normal postmenopausal values during 12-month intravaginal 0.50% DHEA.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Long-term Safety of Intravaginal Prasterone (DHEA): Endometrium |
421; 36 | — |
| PRIMARY Long-term Safety of Intravaginal Prasterone (DHEA): Serum Steroid Levels |
2071.61; 2997.25; 925.65; 6.05; 4.46; -1.59 | — |
| SECONDARY Change From Baseline to Week 52 of Vaginal Cell Maturation (Percentage of Parabasal Cells). |
55.49; 12.81; -42.67; 63.95; 14.80; -49.14 | — |
| SECONDARY Change From Baseline to Week 52 of Vaginal Cell Maturation (Percentage of Superficial Cells). |
2.02; 9.42; 7.41; 0.96; 8.81; 7.85 | — |
| SECONDARY Change From Baseline to Week 52 of Vaginal pH. |
6.23; 5.09; -1.14; 6.40; 5.13; -1.27 | — |
| SECONDARY Change From Baseline to Week 52 of Self-assessment of VVA Symptom Dyspareunia |
2.53; 0.85; -1.68; 2.57; 0.87; -1.69 | — |
| SECONDARY Change From Baseline to Week 52 of Self-assessment of VVA Symptom Vaginal Dryness |
2.22; 0.59; -1.63; 2.19; 0.67; -1.52 | — |
| SECONDARY Change From Baseline to Week 52 of Self-assessment of VVA Symptom Irritation/Itching |
2.10; 0.60; -1.50; 2.13; 0.74; -1.39 | — |
Eligibility Criteria
Main Inclusion Criteria:
- Postmenopausal women (non-hysterectomized)
- Women between 40 and 75 years of age.
- Willing to participate in the study and sign an informed consent.
- Women who have self-identified symptom(s) of vaginal atrophy.
- Willing to have endometrial biopsy at screening and end of study (Week 52).
Main Exclusion Criteria:
- Undiagnosed abnormal genital bleeding.
- Hypertension equal to or above 140/90 mm Hg.
- The administration of any investigational drug within 30 days of screening visit.
- Endometrial hyperplasia, cancer or endometrial histology showing proliferative, secretory or menstrual type characteristics at histologic evaluation of endometrial biopsy performed at screening.
Data sourced from ClinicalTrials.gov (NCT01256671) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.